Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

Miromatrix to respond to FDA clinical hold on miroliverELAP in second half

Miromatrix Medical (NASDAQ:MIRO) has evaluated a clinical hold on its investigational miroliverELAP transplantable organ and plans to submit its response to the FDA in the second half of 2023 and initiate a first-in...

February 1, 2023

Developments

Roth Capital acquires MKM Partners

Roth Capital Partners completed its acquisition of MKM Partners on Jan. 31, and the combined organization will conduct business as ROTH MKM. This is the first acquisition ROTH has made in its 30-plus years of business...

February 1, 2023

Developments

First Wave to initiate Phase 2 trial of enhanced adrulipase formulation

First Wave BioPharma (NASDAQ:FWBI) plans to initiate a Phase 2 clinical trial of an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in...

January 31, 2023

Developments

Reneo receives FDA fast track for of long-chain fatty acid oxidation disorder

The FDA granted Reneo Pharmaceuticals’ (NASDAQ:RPHM) mavodelpar (REN001) fast track designation for long-chain 3-hydroxyacyl-CoA dehydrogenase (LCHAD) deficiency, one of the predominant genotypes in patients with long...

January 31, 2023

Developments

Theralase to present Phase 2 NMIBC interim data at ASCO GU cancer symposium

Interim data from Theralase Technologies’ (TSXV:TLT; OTCQB:TLTFF) Phase 2 non-muscle invasive bladder cancer (NMIBC) clinical study has been accepted by the American Society of Clinical Oncology (ASCO) Genito Urinary...

January 25, 2023

Developments

Precigen posts positive Phase 1 AdenoVerse data in RRP

Precigen (NASDAQ:PGEN) reported positive Phase 1 dose escalation and expansion cohort data as of the Jan. 12, 2023 cut-off for its investigational PRGN-2012 off-the-shelf AdenoVerse immunotherapy in patients with...

January 25, 2023

Developments

CMS sets national pricing for BioStem’s VENDAJE

The Center for Medicare Services (CMS) established national pricing for BioStem Technologies’ (OTCQB:BSEM) VENDAJE in all Medicare Administrative Contractors (MAC) regions, effective Jan. 1, 2023. VENDAJE allografts now...

January 24, 2023

Developments

IntelGenx, ARWAN Pharma in supply agreement for RIZAPORT in MENA countries

IntelGenx (TSX:IGX; OTCQB:IGXT) entered into an exclusive supply agreement for its RIZAPORT product with ARWAN Pharmaceuticals Industries Lebanon for various countries in the Middle East and North Africa, known as the...

January 23, 2023

Developments

Jazz, Zymeworks post positive Phase 2 survival in metastatic gastroesophageal adenocarcinoma

Jazz Pharmaceuticals (NASDAQ:JAZZ) and Zymeworks (NASDAQ:ZYME) reported the first overall survival (OS) data from a Phase 2 trial examining zanidatamab, an investigational HER2-targeted bispecific antibody, in...

January 19, 2023

Developments

Hepion posts positive preclinical results in multiple myeloma expanding rencofilstat’s anti-cancer potential

Hepion Pharmaceuticals (NASDAQ:HEPA) announced positive results of preclinical studies examining rencofilstat as a potential therapeutic for multiple myeloma (MM). Rencofilstat exerted anti-cancer activity across a...

January 18, 2023

Developments

FDA grants Avidity fast tract for facioscapulohumeral muscular dystrophy

The FDA granted Avidity Biosciences (NASDAQ:RNA) fast track designation to the company’s AOC 1020 drug candidate for the treatment of facioscapulohumeral muscular dystrophy (FSHD). FSHD is a serious, rare, hereditary...

January 18, 2023

Developments

Oramed oral insulin flunks Phase 3 Type 2 diabetes trial

Oramed Pharmaceuticals’ (NASDAQ, TASE ORMP) oral insulin drug candidate, ORMD-0801, did not meet its primary endpoint in a Phase 3 clinical trial in patients with Type 2 diabetes (T2D) at 26 weeks. The multi-center ORA...

January 12, 2023

Developments

Hepion presents preclinical study of anti-cancer activity of rencofilstat

Hepion Pharmaceuticals’ (NASDAQ:HEPA) research collaborator presented new findings from a preclinical study on the company’s lead drug candidate, rencofilstat, a potent inhibitor of cyclophilins, at the 2023 State of...

January 11, 2023

Developments

Hepion Pharmaceuticals receives non-dilutive funding

Hepion Pharmaceuticals (NASDAQ:HEPA) received $2.9-million in net proceeds from the sale of tax benefits under the company’s participation in the New Jersey Economic Development Authority (NJEDA) net operating loss...

January 9, 2023

Developments

Hepion to present Phase 2a rencofilstat multiomics data at NASH-TAG 2023

Hepion Pharmaceuticals (NASDAQ:HEPA) will present an abstract highlighting its lead drug candidate, rencofilstat, at the NASH-TAG 2023 Conference in Park City, Utah on Jan. 7. The presentation is entitled, “Rencofilstat...

January 6, 2023

Developments

iBio receives U.S. patent for AI-engineered epitope discovery engine

iBio (NYSEA:IBIO) received a patent from the U.S. Patent and Trademark Office issued a patent entitled, “Machine Learning Method For Protein Modelling To Design Engineered Peptides,” which covers a machine learning...

January 5, 2023

Developments

liberDi receives FDA clearance for digital home dialysis system

liberDi, a portfolio company of The Trendlines Group (OTCQX:TRNLY), received regulatory clearance from the FDA for its Digital Dialysis Clinic, which allows patients to perform dialysis at home or at the workplace, by...

January 4, 2023

Developments

Aravive completes enrolment in Phase 3 ovarian cancer trial

Aravive (NASDAQ:ARAV) achieved full enrollment in a global registrational Phase 3 trial of batiraxcept plus paclitaxel for platinum-resistant ovarian cancer (PROC). The Phase 3 AXLerate-OC trial is evaluating efficacy...

January 4, 2023

Developments

Kiora completes enrollment in persistent corneal epithelial defects trial

Kiora Pharmaceuticals (NASDAQ:KPRX) completed enrollment in its clinical study evaluating KIO-201 in patients with persistent corneal epithelial defects (PCED), a rare ocular condition characterized by non-healing...

January 3, 2023

Developments

Profound Medical CEO adds to holdings, again

According to a filing with SEDI, Profound Medical (NASDAQ:PROF; TSX:PRN) chairman and CEO, Arun Menawat, acquired 13,000 shares of the company at a price of $7.81 (U.S.) each on the open market to hold 425,296 shares...

December 21, 2022

Developments

Zymeworks posts positive pivotal topline data in BTC

Zymeworks (NASDAQ ZYME) reported positive topline results from the pivotal Phase 2b HERIZON-BTC-01 open-label, single-arm clinical trial investigating zanidatamab, a HER2-targeted bispecific antibody, as monotherapy in...

December 19, 2022

Developments

Avidity posts first-ever data targeting delivery of RNA to muscle

Avidity Biosciences (NASDAQ:RNA) reported positive AOC 1001 data from the preliminary assessment of the Phase 1/2 MARINA trial, demonstrating the first-ever successful targeted delivery of RNA into muscle, a...

December 14, 2022

Miromatrix to respond to FDA clinical hold on miroliverELAP in second half

Roth Capital acquires MKM Partners

First Wave to initiate Phase 2 trial of enhanced adrulipase formulation

Reneo receives FDA fast track for of long-chain fatty acid oxidation disorder

Theralase to present Phase 2 NMIBC interim data at ASCO GU cancer symposium

Precigen posts positive Phase 1 AdenoVerse data in RRP

CMS sets national pricing for BioStem’s VENDAJE

IntelGenx, ARWAN Pharma in supply agreement for RIZAPORT in MENA countries

Jazz, Zymeworks post positive Phase 2 survival in metastatic gastroesophageal adenocarcinoma

Hepion posts positive preclinical results in multiple myeloma expanding rencofilstat’s anti-cancer potential

FDA grants Avidity fast tract for facioscapulohumeral muscular dystrophy

Oramed oral insulin flunks Phase 3 Type 2 diabetes trial

Hepion presents preclinical study of anti-cancer activity of rencofilstat

Hepion Pharmaceuticals receives non-dilutive funding

Hepion to present Phase 2a rencofilstat multiomics data at NASH-TAG 2023

iBio receives U.S. patent for AI-engineered epitope discovery engine

liberDi receives FDA clearance for digital home dialysis system

Aravive completes enrolment in Phase 3 ovarian cancer trial

Kiora completes enrollment in persistent corneal epithelial defects trial

Profound Medical CEO adds to holdings, again

Zymeworks posts positive pivotal topline data in BTC

Avidity posts first-ever data targeting delivery of RNA to muscle

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